3M Attest™ Auto-reader, 490 Operating instructions

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Operating instructions

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Description:
DIELINE
Base File Name:
Software:
SGS Contact:
Email:
Printer:
Printer Location:
Supplier:
3MAttest™
Auto-Reader 490H
Requester:
Linda Thompson
Reference:
Die # / Doc. Size:
8.5" x 11"
Item Spec#:
34-8720-4946-4
Supersedes#:
Cat/Product#:
490H
Structure#:
Insert
PA: 490H_34872049464.indb
GA:
InDesign CS14
PROCESS
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3M
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03.21.17 New – updates per word document, set-up for Phase 2 Multi language. Jer
03.22.17 Update with new image. Jer
3M
Attest
Auto-reader 490H
1
Operator’s Manual
2
Manuel de l’utilisateur
3
Benutzerhandbuch
4
Manuale dell’operatore
5
Manual del usuario
5
Manual del operador
6
Bedieningshandleiding
7
Användarhandbok
8
Brugsvejledning
9
Brukerhåndbok
0
Käyttöopas
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Manual do Utilizador
-
Manual do Operador
=
Εγχειρίδιο Χειριστή
H
Instrukcja obsługi
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Příručka pro obsluhu
S
Priročnik za uporabo
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Инструкция по эксплуатации
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Upute za korištenje
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Operatör Kılavuzu
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操作指南
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คู่มือปฏิบัติงาน
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작업자 매뉴얼
1
1
3M Attest Autoreader490H
1
Read and understand all safety information before using this product.
TABLE OF CONTENTS
Preface ....................................................................................................................................................................... 2
IntendedUse ..............................................................................................................................................................2
Indications forUse..................................................................................................................................................... 2
ProductDescription...................................................................................................................................................2
Warranty .....................................................................................................................................................................2
Safety andPrecautions .............................................................................................................................................2
Health and SafetyInformation..................................................................................................................................3
Explanation of Product and Packaging LabelSymbols ..........................................................................................3
Specifications ............................................................................................................................................................4
Instructions for Use ...................................................................................................................................................4
Features ......................................................................................................................................................................7
Care andCleaning .....................................................................................................................................................8
TroubleshootingGuide............................................................................................................................................... 8
Optional 3M
Attest Autoreader490H WebApp ...............................................................................................9
Troubleshooting the 3M
Attest Autoreader490H WebApp ..........................................................................12
Repair andReplacement.........................................................................................................................................12
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PREFACE
Manual RevisionHistory
Date Revision Reason for Revision
November, 2013 A Initial Issue
September, 2014 B
To add network switch requirements to the
WebApp section.
April, 2015 C
Various specification edits/updates.
490H Web App Configuration Page: Added
rows for secondary DNS and MAC address.
BI Activation instructions: added option to
activate 1295 BI using Attest™ BI Activator.
March, 2017 D
Revised to reflect reduced time for final
fluorescent result. Applicable to 3M™
Attest™ Auto-reader 490H software version
4.0.0 or greater.
ContentDisclaimers
PictorialDisclaimer
Sample printouts, graphics, displays and screens are for information and illustration
purposes only, and shall not be used for clinical or maintenance evaluations. Data shown
in sample printouts and screens do not reflect actual testresults.
HardwareDisclaimer
The 3M™ Attest™ Autoreader 490H hardware specifications are subject to change.
The system images, hardware components and hardware specifications included in
the manual may not match the system installed. Any changes or modifications to the
authorized system installation have been verified as compatible with the functionality
outlined in thisdocument.
INTENDEDUSE
The 3M™ Attest™ Rapid Readout Biological Indicator System for Vaporized Hydrogen
Peroxide Sterilization provides rapid and reliable routine monitoring of vaporized hydrogen
peroxide sterilization processes in health care facilities. The system is comprised of an
incubator/reader with embedded software, the 3M™ Attest™ Autoreader 490H, and a
biological indicator, the 3M™ Attest™ Rapid Readout Biological Indicator1295.
INDICATIONS FORUSE
The 3M™ Attest™ Autoreader 490H is designed to incubate and automatically read the
3M™ Attest™ Rapid Readout Biological Indicator 1295at 60°C for a final fluorescent
result at 24 minutes.
PRODUCTDESCRIPTION
The 3M™ Attest™ Rapid Readout Biological Indicator System for Vaporized Hydrogen
Peroxide Sterilization provides rapid, reliable routine monitoring of hydrogen peroxide
vapor sterilization processes performed in health care facilities. The system is comprised
of a biological indicator and an incubator/reader (3M™ Attest™ Autoreader 490H) with
embedded software. The 3M™ Attest™ Autoreader 490H is designed to incubate and
automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295at 60°C for a
final fluorescent result at 24 minutes.
The 3M™ Attest™ Autoreader 490H is also designed to allow for further incubation
of positive control 3M™ Attest™ Rapid Readout Biological Indicators 1295for a final
positive visual pH color change result at 24hours. It is recommended that processed BIs
be transferred to a humidified incubator for further incubation. A final negative visual pH
color change result is assessed after 7days. This further incubation is optional and not
intended for routineuse.
A positive fluorescence reading or a positive visual pH color change result indicate a
sterilization process failure. However, due to the high sensitivity of the fluorescent result,
there is no advantage to continuing to incubate processed 3M™ Attest™ Rapid Readout
Biological Indicators 1295once the fluorescent result has beendocumented.
Other biological indicators (BIs) are not compatible with this device and cannot beused.
WARRANTY
The 3M™ Attest™ Autoreader 490H has a one year limited product warranty. The
USwarranty, remedy and limitations are described in the Price Quote form and in the
Direct Price Pages. For countries outside of the US, any warranty is established by the
subsidiary with responsibility for service of the 3M™ Attest™ Autoreader490H.
SerialNumber
For easy identification, each 3M™ Attest™ Autoreader 490H has a unique serial number
printed on a label found on the back of the unit and displayed on the left side of the upper
row of text on the LCD display when the user depresses the button. Please record
your serial number in this manual for future reference:___________________.
SAFETY ANDPRECAUTIONS
The 3M™ Attest™ Autoreader 490H and its related devices and accessories are
designed to provide safe and reliable service when used according to the instructions
provided. Please read, understand, and follow all safety information contained in
the instructions for use included with the 3M™ Attest™ Autoreader 490H and the
3M™ Attest™ Rapid Readout Biological Indicator 1295devices prior to use. Use this
equipment only for the purpose described in this Operators Manual. Retain these
instructions for futurereference.
The unit is designed to be used only with the Power Supply module and Ethernet cable
supplied by 3M. If this product is used in a manner not specified, the protection provided
by the product may beimpaired.
Explanation of Single WordConsequences
Warning: Indicates a hazardous situation, which, if not avoided, could result in
death or seriousinjury.
Caution: Indicates a hazardous situation, which, if not avoided, could result in
minor or moderateinjury.
Warnings and SafetyPrecautions
The following warnings and precautions should be followed to avoid unsafe actions that
could result in personal injury or damage to theinstrument.
WARNING: To reduce the risk associated with hazardous voltage
Use indoors only.
Do not use the equipment if it is not working properly or if it has suffered any damage.
Use only the power supply specified for this product and certified for the country
ofuse.
CAUTION: To reduce the risk of injury or instrument damage
Do not spill liquid onto or into the instrument. Do not immerse the unit in liquid.
Always unplug the 3M™ Attest™ Autoreader 490H and allow to cool before cleaning.
Clean external surfaces using only the instructions provided by the manufacturer.
Do not open the instrument housing there are no user serviceable parts. The
instrument must be returned to the manufacturer for repair.
Wear safety glasses and gloves when activating the 3M™ Attest™ Rapid
ReadoutBiological Indicator 1295.
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WARNING: To reduce the risk associated with incorrect results
Instrument is to be used by operators familiar with the device, device functionality, and
Operators Manual.
Do not place the instrument in environment exposed to sunlight or strong
incandescent light.
Do not place instrument close to any device that emits a strong electromagnetic field.
Do not use on a vibrating surface.
Activate and incubate 3M™ Attest™ Rapid Readout Biological Indicators 1295within
1hour of the completion of the sterilization cycle.
Do not incubate a 3M™ Attest™ Rapid Readout Biological Indicator 1295if, after
processing and before BI activation, it is observed to have a broken media ampoule.
Retest the sterilizer with a new biological indicator.
Incubate the 3M™ Attest™ Rapid Readout Biological Indicator 1295only in the
3M™ Attest™ Autoreader 490H i.e., match the pink cap color of the 1295BI with
the pink colorcoded configuration sticker surrounding the 3M™ Attest™ Autoreader
490H incubation wells.
Do not remove the 3M™ Attest™ Rapid Readout Biological Indicator from the
incubation well until the (+) or () symbol on the LCD display indicates the test
iscomplete.
Caution: To reduce the risk associated with incorrect results
To avoid the possibility of the 3M™ Attest™ Rapid Readout Biological Indicator
1295vial absorbing fluorescent residue from a chemical indicator or tape, place the
3M™ Attest™ Rapid Readout Biological Indicator vial so it does not come in direct
contact with chemical indicators or tape.
HEALTH AND SAFETYINFORMATION
Device SafetyCompliance
The 3M™ Attest™ Autoreader 490H complies with the following standards as
demonstrated by the CB Scheme Certificate and test report issued by Underwriters
Laboratories(UL):
IEC 610101 (2010) 3rd Edition. Safety requirements for electrical equipment for
measurement, control, and laboratory use Part 1: General requirements
IEC 610102010: 2014 3rd Edition. Safety requirements for electrical equipment for
measurement, control, and laboratory use Part 2010: Particular requirements for
laboratory equipment for the heating of materials
The 3M™ Attest™ Autoreader 490H is listed as Laboratory equipment and carries the
UL mark with adjacent indicators C and US based on compliance to the standards UL
610101, CAN/CSA C22.2 No. 61010-1 and CAN/CSA C22.2 No. 61010-2-010.
The 3M™ Attest™ Autoreader 490H complies with the CE mark related to the Low
Voltage Directive (LVD) 2006/95/EC as confirmed in the Declaration ofConformity.
The 3M™ Attest™ Autoreader 490H complies with the RoHS Directive, Directive
2011/65/EU of the European Parliament and of the Council of 8June 2011on
the restriction of the use of certain hazardous substances in electrical and
electronicequipment.
The 3M™ Attest™ Autoreader 490H complies with the WEEE Directive, Directive
2012/19/EU of the European Parliament and of the Council of 04July 2012on waste
electrical and electronic equipment(WEEE).
EMCCompliance
The 3M™ Attest™ Autoreader 490H complies with the following EMC standards as
confirmed in the Certificate of Compliance generated by3M:
IEC 613261:2012/EN 61326:2013 Electrical equipment for measurement, control and
laboratory use EMC requirements Part 1: General requirements
EMC requirements of the CE mark EMC Directive2004/108/EC.
The 3M™ Attest™ Autoreader 490H complies with the Australian and New Zealand
electrical safety and electromagnetic compatibility requirements as confirmed in the
Suppliers Declaration of Conformity that is linked to the Australian/New Zealand RCM
(Regulatory ComplianceMark).
Note: This equipment has been tested and found to comply with the limits for a Class A
digital device pursuant to Part 15, Subpart B, of the FCC Rules. These limits are designed
to provide a reasonable protection against harmful interference when the equipment is
operated in a commercial environment. This equipment generates, and can radiate radio
frequency energy and, if not installed and used in accordance with the instruction manual,
may cause harmful interference to radio communications. Operation of this equipment
in a residential area is likely to cause harmful interference in which case the user will be
required to correct the interference at their ownexpense.
This Class A digital device meets all requirements of the Canadian InterferenceCausing
EquipmentRegulations.
EXPLANATION OF PRODUCT AND PACKAGING
LABELSYMBOLS
Attention Refer to the instructions foruse
Waste Electrical and Electronic Equipment (WEEE) and EU Battery Directive.
This symbol indicates that both the device and the lithium ion battery
contained therein need to be disposed ofproperly.
UL Listed to US and Canadian SafetyStandards
Mark of Conformity to EuropeanDirectives
Directcurrent
Compliant to all applicable ACMA regulatory arrangements(RCM)
Manufacturer
Catalognumber
Authorized representative for the EuropeanCommunity
Serialnumber
Li
REF
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SPECIFICATIONS
Power SupplySpecifications
Power supply Operating Condition Units
Voltage Range 100240 Volts AC
Frequency 50/60 Hertz
Current 0.6 Amps
Environmental OperatingConditions
Environmental Condition Operating Condition Units
Altitude 3000(max) Meters
Operating Temperature 16 40 ºC
Storage Temperature 10to 50 ºC
Operating Relative Humidity 2080(noncondensing) %
Voltage Range 12 VoltsDC
Frequency DC
Current 1.2 Amps
Installation/Over Voltage CategoryII
Pollution Degree 2
INSTRUCTIONS FOR USE INITIALSETUP
ChooseLocation
Place 3M™ Attest™ Autoreader 490H on a firm and level surface, away from sunlight
and incandescent light. To save counter space, units may be stacked twohigh.
WARNING:
Do not place the instrument in environment exposed to sunlight or strong
incandescentlight.
Do not place instrument close to any device that emits a strong
electromagneticfield.
Do not use on a vibrating surface.
Select & Install Correct PowerPlug
The 3M™ Attest™ Autoreader 490H power supply comes with multiple blade
configurations. Install the blade configuration appropriate for your country into the power
supply and plug into appropriate AC groundedoutlet.
WARNING: Use only the power supply specified for this product and certified for
the country of use.
Wait 30Minutes BeforeUsing
Once plugged in, allow a 30minute warmup period before placing 3M™ Attest™ Rapid Readout Biological Indicators 1295into the incubation wells. The C1caution code will
disappear when proper incubation temperature isreached.
SpecialConsiderations
It is recommended that the unit be left on to eliminate warm-up periods. The unit may be turned off when it is anticipated that it will not be used for an extendedperiod.
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INSTRUCTIONS FOR USE WELLS, BUTTONS, & DISPLAYINTERPRETATION
Please familiarize yourself with the face of the 3M™ Attest™ Autoreader490H:
Wells
1. Incubation/Reader Wells The 3M™ Attest™ Autoreader 490H has ten
incubationwells.
Buttons
2. Information / Up ArrowButton
3. Temperature / Down ArrowButton
4. Buzzer Alarm OFF / EnterButton
InformationDisplay
5. LCD display Display isbacklit
6. LCD display Example of Error Message for well#6
7. LCD display Example of Remaining Incubation Time, in minutes, for well#10
8. LCD display Example of Negative ( ) BI result for well#9
9. LCD display Example of Positive ( + ) BI result for well#8
10. LCD display Alarm EnabledIndicator
ColorCoded ConfigurationIndicator
11. Incubation well configuration sticker is colorcodedpink
INSTRUCTIONS FOR USE
3M
ATTEST AUTOREADER490HCONFIGURATION
Note: Ideally, the 3M™ Attest™ Autoreader 490H should be empty (i.e., have no
incubating BIs) when it isreconfigured.
Press the
and buttons on the front of the 3M™ Attest™ Autoreader 490H
simultaneously for 3seconds to enter configuration mode. Once in configuration mode,
use the Up
and Down buttons to set the 3M™ Attest™ Autoreader 490H
clock and audible alarm as desired. The button
acts as an Enter key and moves the
flashing cursor to the next changeablesetting.
Setting the 3M Attest Autoreader 490HClock
The 3M™ Attest™ Autoreader 490H date and time are displayed in this format:
YYYYMMDD HH:MM, with the time displayed using a 24hour clock. To change the
year, if necessary, push the up or down buttons to set desired year, then press
to
advance to the month, adjust as necessary and press
to advance to the day. Use the
button to move to the time and set the hours andminutes.
Setting the Audible AlarmFunction
Move across the top row of text by pushing the button. The flashing B in Buzzer
indicates this is a changeable setting. It is recommended this be set at Buzzer Enabled
to audibly alert the operator to a positive BI but it may be set to Buzzer Disabled by
using either the up or down button. Note: If Buzzer Disabled is selected, and the change is
accepted, the speaker icon (
) will disappear from the LCD panel and the alarm will be
disabled for all positive 3M™ Attest™ Rapid Readout Biological Indicators, error codes,
and caution code alarmwarnings.
Note: The 3M™ Attest™ Autoreader 490H display backlight flashes whenever an
audible alarm sounds. Disabling the audible alarm does NOT disable the LCD display
backlightflashing.
Press
to select the desired option and advance to the Acceptscreen.
AcceptScreen
Use the up or down buttons to toggle between Yes and No, press to accept changes
(Yes selected) or retain current settings (No selected) and exit the configuration mode. The
LCD panel will return to the standarddisplay
.
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INSTRUCTIONS FOR USE READOUTPROCEDURE
Instructions for Biological Indicator (BI) Activation andIncubation
CAUTION: To avoid the possibility of the 3M™ Attest™ Rapid Readout
Biological Indicator 1295vial absorbing fluorescent residue from a chemical indicator
or tape, place the 3M™ Attest™ Rapid Readout Biological Indicator vial so it does not
come in direct contact with chemical indicators or tape.
WARNING: To reduce the risk associated with incorrect results
Do not incubate a 3M™ Attest™ Rapid Readout Biological Indicator 1295if, after
processing and before BI activation, it is observed to have a broken media ampoule.
Retest the sterilizer with a new biological indicator.
Activate and incubate 3M™ Attest™ Rapid Readout Biological Indicators 1295within
1hour of the completion of the sterilization cycle.
Incubate the 3M™ Attest™ Rapid Readout Biological Indicator only in the
3M™ Attest™ Autoreader 490H i.e., match the pink cap color of the 1295BI with
the pink colorcoded configuration sticker surrounding the 3M™ Attest™ Autoreader
490H incubation wells.
CAUTION: Wear safety glasses and gloves when activating the 3M™ Attest™
Rapid Readout Biological Indicator 1295.
Follow this procedure for every 3M™ Attest™ Rapid Readout Biological Indicator (BI) to
beread.
or
While wearing safety glasses and gloves,
PLACE BI in colorcoded 3M™ Attest™
Autoreader490H well. Note that BI
vial is keyed for specific orientation
in well (flat back of BI faces back of
3M™ Attest™ Autoreader490H).
While wearing safety glasses and gloves,
PLACE BI in Attest™ Biological Indicator
Activator.
or
CLOSE BI cap and CRUSH media
ampoule by firmly pushing vial straight
down in incubationwell.
CLOSE and SQUEEZE Attest™ Biological
Indicator Activator to close BI cap and crush
media ampoule.
Immediately remove BI, visually VERIFY the glass ampoule
(containing growth media) has been crushed, and FLICK BI to
ensure purple growth media flows to the growth chamber at the
bottom of thevial.
PLACE the activated BI into a 3M™ Attest™ Auto-reader 490H
well and observe 3M™ Attest™ Auto-reader 490H LCD display
to confirm correct placement of the BI. If the BI is correctly
seated, the 3M™ Attest™ Auto-reader 490H LCD display will
show ***, **, * and then remaining minutes of incubation directly
below the incubating BI.
RECORD BIresult.
WARNING: Do not remove the 3M™ Attest™ Rapid Readout Biological
Indicator 1295from the incubation well until the (+) or () symbol on the LCD display
indicates the testis complete.
INSTRUCTIONS FOR USE ADDITIONALINFORMATION
BIPlacement
Remaining incubation time, in minutes, will be displayed on the LCD display to indicate
the 3M™ Attest™ Rapid Readout Biological Indicator is incubating in the reader well and
should not be touched. The time remaining display indicates the result is not available and
incubation is inprogress.
Do not remove 3M™ Attest™ Rapid Readout Biological Indicator until the (+) or (-)
symbol on the LCD panel indicates the test is complete. Once the result is determined,
it is continuously displayed on the LCD panel until 10seconds after the BI has been
removed from the incubationwell.
Note: After the first minute of incubation, if 3M™ Attest™ Rapid Readout Biological
Indicator is inadvertently removed before the incubation period is complete, an alarm will
sound and a C2Caution code will be displayed on the LCD panel under that well. You
must return the 3M™ Attest™ Rapid Readout Biological Indicator to the reader well
within 10seconds or the results will belost.
WARNING: Do not remove or change placement of 3M™ Attest™ Rapid
Readout Biological Indicator once it is placed into a well. Doing so may result in loss of
results and the 3M™ Attest™ Rapid Readout Biological Indicator test may be invalid.
INSTRUCTIONS FOR USE POSITIVECONTROL
PositiveControl
Activate and incubate at least one nonprocessed 3M™ Attest™ Rapid Readout Biological
Indicator 1295to use as the positive control each day that a processed 3M™ Attest™
Rapid Readout Biological Indicator 1295is incubated and read by the unit. Write a C (for
control) and the date on the label. The positive control can be placed in any incubation
well. The positive control should be the same part number and have the same lot number
as the processed 3M™ Attest™ Rapid Readout Biological Indicator in theunit.
The positive control biological indicator helpsconfirm:
correct incubation temperatures are met (heater block reading of 60°C+/2°C);
viability of spores has not been altered due to improper storage temperature, humidity,
or proximity tochemicals;
capability of media to promote rapid growth;and
proper functioning of 3M™ Attest™ Autoreader 490Hcomponents.
INSTRUCTIONS FOR USE INTERPRETATION OFRESULTS
FluorescentResults
After placing a 3M™ Attest™ Rapid Readout Biological Indicator into an incubation
well, the 3M™ Attest™ Autoreader 490H LCD display will show ***, **, * and then
the remaining minutes of incubation directly below the incubating BI to indicate that
incubation/reading is inprogress. The 3M™ Attest™ Rapid Readout Biological Indicator
should not be removed or touched when the display indicates remaining incubation time.
A (+) will display on the LCD panel directly under the BI and an alarm will sound (if the
sound feature is enabled) as soon as a positive 3M™ Attest™ Rapid Readout Biological
Indicator result isdetected.
At the end of the specified incubation time, if a negative 3M™ Attest™ Rapid Readout
Biological Indicator result is detected, a () will display on the LCD panel directly under
the incubating BI. The final negative fluorescent result () for a processed 3M™ Attest™
Rapid Readout Biological Indicator 1295indicates an acceptable sterilizationprocess.
After either the (+) or () symbol is displayed, and the result is recorded, the
3M™ Attest™ Rapid Readout Biological Indicator can be removed from the well. Do not
re-incubate BIs as the result will not be valid.
The positive (unprocessed) control 3M™ Attest™ Rapid Readout Biological Indicator
1295must provide a positive fluorescent result (+). Processed 3M™ Attest™ Rapid
Readout Biological Indicator results are not valid until the positive control reads fluorescent
positive(+).
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With a processed 3M™ Attest™ Rapid Readout Biological Indicator, a positive (+) result
indicates a sterilization process failure. Act on any positive test results immediately.
Determine the cause of the positive 3M™ Attest™ Rapid Readout Biological Indicator and
retest the sterilizer following current facility policies andprocedures.
Optional Visual pH Color ChangeResult
3M™ Attest™ Rapid Readout Biological Indicators 1295 for Vaporized Hydrogen Peroxide
Sterilization may be further incubated for a visual pH color change. Due to the high
sensitivity of the fluorescent result, there is no advantage to continuing to incubate 3M™
Attest™ Rapid Readout Biological Indicators 1295 after the fluorescent result has been
determined and documented. This optional further incubation is not intended for routine
use but may be used for special studies.
In the case of a positive control BI, a yellow color change of the growth media will appear
within 24hours. Any observation of a yellow color within the vial indicates a positive
result. The pH color change result can be recorded and the BI discarded as soon as the
yellow color is observed and the resultrecorded.
For processed 3M™ Attest™ Rapid Readout Biological Indicators 1295, the use of a
humidified incubator is recommended to avoid media dry out. If a visual pH color change
result is desired, transfer the processed 1295BI to a humidified incubator after the
fluorescent result has been determined in the 3M™ Attest™ Autoreader 490H. A media
color change from purple to yellow indicates a sterilization process failure. A negative pH
color change result, i.e., media remains purple, can be assessed at 7days.
INSTRUCTIONS FOR USE DISPOSAL
Instrument contains a lithium battery. Dispose of instrument in accordance with federal,
state, and localrequirements.
FEATURES OF THE 3M ATTEST AUTOREADER490H
Audible Alarm
An audible alarm will sound, the LCD display backlight will flash, and a (+) symbol will
be displayed on the LCD panel directly under the incubating BI when a positive result is
detected. An alarm will also sound if a 3M™ Attest™ Rapid Readout Biological Indicator
is removed from the 3M™ Attest™ Autoreader 490H well before a final result has been
detected. Data will be lost if the 3M™ Attest™ Rapid Readout Biological Indicator is not
replaced in the incubation well within 10seconds.
AlarmOn/Off
The audible alarm for positive results can be turned off for a particular 3M™ Attest™
Rapid Readout Biological Indicator. This is accomplished by pressing the Buzzer Alarm
OFF button after the alarm has sounded. This will turn off the alarm for that BI only. Any
positive 3M™ Attest™ Rapid Readout Biological Indicator results subsequently detected
in other wells will result in the alarm sounding. Removing the 3M™ Attest™ Rapid
Readout Biological Indicator will reactivate the alarm for that well. Pressing the Buzzer
Alarm OFF button will not silence the alarm for error or caution code alarm warnings. To
disable the alarm, see configurationsection.
Stackable
To save counter space, 3M™ Attest™ Autoreaders 490Hs may be stacked twohigh.
InformationButton
When the Information button is pressed once the 3M™ Attest™ Autoreader 490H
displays two lines of text in the LCDdisplay.
The top row indicates (left toright):
3M™ Attest™ Autoreader 490H serialnumber
3M™ Attest™ Autoreader 490H embedded software version (VX.Y.Z)
Current date andtime.
The bottom row indicates (left toright):
The BI type configuration for wells 15(i.e.,1295)
The BI type configuration for wells 610(i.e.,1295)
Press the information button twice and the 3M™ Attest™ Autoreader 490H LCD display
will present two additional lines oftext.
The top rowindicates:
IP address (if unit is connected to an Ethernetjack).
The bottom row indicates (left toright):
Date (YYYYMMDD) and time that power was supplied to the 3M™ Attest™
Autoreader490H.
Press the information button three times and the 3M™ Attest™ Autoreader 490H LCD
display will present the unique Media Access Control (MAC) Address for thedevice.
TemperatureMonitoring
The 3M™ Attest™ Autoreader 490H contains an internal temperature selfdiagnostic
program. Should the temperature fall outside the specified range (60ºC +/2ºC) an error
code will be displayed. The heater block temperature may be checked by depressing the
Temperature buttononce.
EasyConfiguration
The 3M™ Attest™ Autoreader 490H may be configured using either the buttons located
on the front of the unit or using the optional 3M™ Attest™ Autoreader 490H Web App.
Optional 3M Attest Autoreader 490H Web App
If desired, the 3M™ Attest™ Autoreader 490H may be connected to a PC via an Ethernet
connection for additionalcapabilities:
Remotely view current status of BIs in the 3M™ Attest™ Auto-reader 490H via
networked PC or mobile hand held devices. For full functionality, the use of an HTML5
compliant browser with JavaScript enabled is required.
Remotely view and configure 3M™ Attest™ Autoreader 490Hsettings.
View the last 100BIrecords.
Print out documentation using a local or networked printer and/or save documentation
as an electronicfile.*
Note: To access the 3M™ Attest™ Autoreader 490H Web App within a secure network,
the PC or mobile device must have access to the secure network; options include
connecting via a network Ethernet cable, signing in to the facilitys wireless network, or
connecting via a virtual private network(VPN).
* Refer to your facilitys record keeping policy andprocedure.
8 9
1
CARE ANDCLEANING
Clean the exterior surface of the 3M™ Attest™ Autoreader 490H by wiping it with a
damp cloth moistened with a mild detergent. Do not attempt to clean interior components.
If additional cleaning of the wells is required, call for repair orreplacement.
Note: The 3M™ Attest™ Autoreader 490H does not contain any user serviceable parts
or require any routine maintenance or calibration. Any malfunctions will be indicated by an
error code. Refer to the Troubleshooting Guide section for error codeexplanations.
CAUTION: Always unplug the 3M™ Attest™ Autoreader 490H and allow to
cool before cleaning.
Do not spill liquid onto or into the instrument. Do not immerse the unit in liquid.
Clean external surfaces using only the instructions provided by the manufacturer.
Do not open the instrument housing there are no user serviceable parts. The
instrument must be returned to the manufacturer for repair.
TROUBLESHOOTINGGUIDE
In the event of an error code, unplug the 3M™ Attest™ Autoreader 490H and plug it back in to initiate the selfdiagnostic test. If error code reoccurs, call for repair orreplacement.
The LCD display will indicate detected malfunctions by displaying a caution or error code under affected BI wells. The audible alarm, if active, sounds and the LCD display backlight
flashes to alert the user to all caution (except C1) and error codes. The alarm and backlight can be silenced and extinguished, respectively, by pressing the Buzzer Alarm OFF button .
Note that disabling the audible alarm does not disable the flashing LCD display backlight. Refer to thefollowing:
Code/ Issue Problem Solution
C1
Unit WarmupCaution
Incubation block not at temperature.
Allow a 30minute warmup after 3M™ Attest™ Autoreader 490H is
plugged in. (Note: 3M™ Attest™ Rapid Readout BI readings are disabled until
incubator block reaches 60ºC +/ 2ºC).
C2
BI Removed from WellCaution
3M™ Attest™ Rapid Readout BI has been removed before incubation is complete.
Replace 3M™ Attest™ Rapid Readout BI in proper well within 10seconds to
prevent loss of collected data.
C4 Ambient Light Caution
Move 3M™ Attest™ Autoreader 490H to reduced ambient light conditions.
E1
Temperature ControlError
This error will occur if system is no longer able to control the temperature of the
incubator block (60ºC +/ 2ºC ).
Unplug the unit and plug it back in to clearerror.
If error doesnt clear, call for repair or replacement.
E3
MemoryError
3M™ Attest™ Autoreader 490H unable to save/read data from memory.
Unplug the unit and plug it back in to clearerror.
If error doesnt clear, call for repair or replacement.
E7
Communications Error
This error will occur if internal communications have failed.
Unplug the unit and plug it back in to clear error. If error doesnt clear, call for
repair or replacement.
E8
LEDError
This error occurs for a specific well if the system detects that a UV LED or Optics
Detection circuit is not working.
Unplug the unit and plug it back in to clearerror.
If error doesnt clear, call for repair or replacement. Do not use affected
incubation well.
E11
BI Inserted IncorrectlyError
Incubation time remaining will not display and fluorescent readings are not taken.
Remove BI and inspect to verify cap is fully closed, glass ampoule is crushed,
and growth media is in growth chamber. If necessary, repeat BI activation
steps: place & push BI down FIRMLY into incubation well; remove BI and flick
it; inspect BI; and return BI to incubation well, ensuring it is seated properly.
E12
Power FailureError
Power to Autoreader was off for too long to provide valid result for affected BI(s).
Ensure power supply connection to Autoreader is secure. Retest sterilizer
with a new BI.
E14
Ambient Light Error (occupiedwell)
Fluorescent result will not display.
Rely on optional visual pH color change result for BI in affected well. Move
3M™ Attest™ Autoreader 490H to reduced ambient light conditions to avoid
future occurrences. To clear E14error code, after visual pH color change result
has been documented and BI has been removed, unplug the 3M™ Attest™
Autoreader 490H and plug it back in.
Other Unwanted alarm sounds when positive BI detected.
Disable alarm; refer to 3M™ Attest™ Auto-reader 490H Configuration
section for instructions.
Other
AlarmSounds
3M™ Attest™ Rapid Readout Biological Indicator has been removed from
incubation/reader well prematurely.
Replace 3M™ Attest™ Rapid Readout Biological Indicator in incubation/
reader well within 10seconds to prevent loss of data collected.
Other LCD display does not display properly.
Unplug the unit and plug it back in. If problem persists call for repair
orreplacement.
Other
Negative Control Vial
BI not properly activated/ media did not contact spore carrier.
Ensure BI cap is closed and glass ampoule is crushed. Flick BI until media
flows to spore chamber at bottom of BI.
8 9
1
Code/ Issue Problem Solution
Other
Negative Control Vial
Control vial was sterilized.
Check process indicator on BI cap. Use a nonsterilized vial as a control.
Other
Unexplained PositiveBI
Adhesive residue on vial.
Do not place tape or labels on vial.
Other
Unexplained PositiveBI
Test vial is absorbing fluorescent residue from a chemical indicator or tape.
Place the vial so it does not come in direct contact with chemical indicators
or tape.
Other
3M™ Attest™ Autoreader 490H will not enter Configurationmode.
Pushbutton Configuration may be disabled on 3M™ Attest™ Autoreader 490H
Web App.
On 3M™ Attest™ Autoreader 490H Web App Configuration Page, go to
Pushbutton Configuration and select the Enable radio button. Save changes to
begin using new setting.
Other
3M™ Attest™ Autoreader 490H LCD display flashes and asterisks (***) and/or
E11and/or C4codes appear on display below unoccupied incubation wells.
Move 3M™ Attest™ Autoreader 490H away from sunlight or sources of
incandescent light.
OPTIONAL 3M ATTEST AUTOREADER 490H WEB APP
Web BrowserRequirements
The web interface is designed to be viewed in Internet Explorer 8.0 or higher. Earlier
versions of Internet Explorer or other browsers may result in some web pages being
displayed in a less-than-optimal manner. For best results, switching to Internet Explorer
8.0 or higher is recommended. For full functionality, the use of an HTML5 compliant
browser with JavaScript enabled is required.
EthernetConnection:
Connection switch/router with autonegotiation capability to identify the Autoreader as
operating at 10Mbps and halfduplex, or able to be manually configured as 10Mbps
andhalfduplex.
Connecting to the 3M Attest Autoreader 490H Web App
To use the 3M™ Attest™ Auto-reader 490H Web App, the 3M™ Attest™ Auto-reader
490H must be connected to the facility network using the supplied Ethernet cable. Consult
with your facility IT personnel for assistance with network connectivity. Each 3M™
Attest™ Auto-reader 490H has a unique MAC Address which is presented on the units
LCD display when the user depresses the Info button three times. The MAC Address is also
provided at the bottom of the 3M™ Attest™ Auto-reader 490H Web App Configuration
page. Communication occurs using the http protocol over Port 80. The 3M™ Attest™
Auto-reader 490H does not collect, process, store, or transmit any Protected Health
Information (PHI). Web App Users may connect to the 3M™ Attest™ Auto-reader 490H
Web App using a URL based upon either the 3M™ Attest™ Auto-reader 490H serial
number or the IP Address. To view the 3M™ Attest™ Auto-reader 490H Web App from a
wireless device such as a mobile hand-held device or a computer on a sub-net different
from that to which the 3M™ Attest™ Auto-reader 490H is connected, use the IP Address
URL.
Note: To access the 3M™ Attest™ Autoreader 490H Web App within a secure network,
the PC or mobile device must have access to the secure network; options include
connecting via a network Ethernet cable, signing in to the facilitys wireless network, or
connecting via a virtual private network(VPN).
A. Serial numberURL
1. Connect the supplied Ethernet cable from the 3M™ Attest™ Autoreader 490H to an
Ethernetjack.
2. Depress the
button once to display the 3M™ Attest™ Autoreader 490H 6digit
serial number on the left side of the top row of text on the LCDdisplay.
3. Enter http://attestxxxxxx, where xxxxxx represents the units serial number (e.g., http://
attest221008) from Step 2, in the PC web browser address bar and pressEnter.
4. The 3M™ Attest™ Autoreader 490H Web App Status page will display on the PC. For
future ease of use, add this page to your web browser Favorites.
B. IP AddressURL
The 3M™ Attest™ Autoreader 490H Web App may also be accessed using either a
dynamic or static IPaddress.
1. Dynamic IP Address
A dynamic IP address is assigned when the Ethernet cable is connected from the
3M™ Attest™ Autoreader 490H to a live Ethernetjack.
Press and release the
button twice to display the dynamic IP address for the
3M™ Attest™ Autoreader 490H. Enter http://IPaddress (e.g. http://123.456.789.012) in
the web browser address bar of the PC or mobile handheld device and press Enter. The
3M™ Attest™ Autoreader 490H Web App Status page willdisplay.
2. Static IPaddress
Some facility IT personnel may require devices connecting to the network to use a Static
IP address. If this is the case at your facility, contact the IT department to request a Static
IPaddress.
Record the static IP address provided by your facility IT department here:___________.
You may wish to label the Ethernet jack with the assigned address. Enter
http://StaticIPaddress (e.g. http://111.222.333.444) in the web browser address bar on
your PC or mobile handheld device and press Enter. The 3M™ Attest™ Autoreader 490H
Web App Status page willdisplay.
About the 3M Attest Autoreader 490H Web AppPages
The 3M™ Attest™ Autoreader 490H Web App includes fourpages.
a) Statuspage
Status
History
3M™ Attest™ Auto-reader 490H
AT TEST 1295 AT TEST 1295
Auto-reader 490H
1 2 3 4 5
+24
678910
SN
200299
2017- 0 5 -11 17:13
1. Userentered nickname(optional)
2. Well Configuration (15and610)
3. WellNumber
4. BI Result/Remaining Incubation Time
5. Date and Time
6. 3M™ Attest™ Autoreader 490H SerialNumber
The Status page provides a realtime representation of the 3M Attest™ Autoreader
490H LCD panel display. The current date and time and 3M™ Attest™ Autoreader 490H
serial number are also indicated on this page. From this page, the user may navigateto:
the History page by clicking on History on the left of thescreen.
the Results Detail page by clicking on the well number of an occupied well (i.e., a well
that currently has an incubating BI). Clicking on an unoccupied well takes the user to
the Historypage.
10 11
1
b) Results Detailpage
3M™ Attest™ Auto-reader 490H Results Detail
Status
History
Print
Result
Start Time
Well# and Configuration
490H Serial Number
Control?
BI Lot#
Load#
Sterilizer#
Technician
Chemical Integrator?
Implant?
Cycle Parameters
Notes
no
2018-12DA
1
6
sdf
n/a
n/a
n/a
Daily control BI
2017-05-11 08:05:42
#2 1295
200299
This page provides an individual record for an incubated BI. For complete documentation,
the user may print a hard copy and/or save the record as an electronicfile.
Note 1: The top four rows (highlighted in green) are populated automatically by the
3M™ Attest™ Autoreader 490H and cannot be changed by the user. The remaining rows
are completed by the user to satisfy the documentation requirements of theirfacility.
Note 2: The Results Detail page refreshes less frequently that the Status page. Until the BI
result is available, the Results Detail page displays remaining minutes of incubation in the
resultsfield.
c) Historypage
Status
History
3M™ Attest™ Auto-reader 490H
Well# and Configuration
#3 1295
#2 1295
#1 1295
#10 1295
#3 1295
#2 1295
#1 1295
#4 1295
#3 1295
#2 1295
Start Time
2017-05-11 13:51:49
2017-05-11 08:05:42
2017-05-11 08:03:56
2017-05-07 11:55:16
2017-05-07 11:06:44
2017-05-07 08:03:19
2017-05-07 08:02:43
2017-05-04 08:57:51
2017-05-04 08:57:12
2017-05-04 08:01:47
Result
---
+
+
ID
1
2
3
4
5
6
7
8
9
10
The 3M™ Attest™ Autoreader 490H stores results for the last 100incubated BIs on
embedded software. The 3M™ Attest™ Autoreader 490H Web App History page provides
a summary of these last 100results.
d) Configurationpage
This page allows the configuration of the network and language settings for the
3M™ Attest™ Autoreader 490H from the 3M™ Attest™ Autoreader 490H Web App.
Documenting BI Results using the 3M Attest Autoreader 490H
Web App
Status
History
3M™ Attest™ Auto-reader 490H
AT TEST 1295 AT TEST 1295
Auto-reader 490H
1 2 3 4 5
+24
678910
SN
200299
2017- 0 5 -11 17:13
1. Open the Results Detailpage
After inserting a new 3M™ Attest™ Rapid Readout BI in the 3M™ Attest™
Autoreader 490H, it is a best practice to open the 3M™ Attest™ Autoreader 490H
Web App Results Detail page for that BI by clicking on the appropriate well number
from the Statuspage.
2. Enter the specific information for that BI (e.g., BI Lot #, sterilizer #, load #, technician
name, etc.) in the provided editable fields. Use the Notes section to capture
information not prescribed in the provided row titles; for example, you may wish to use
this field to record loaditems.
3M™ Attest™ Auto-reader 490H Results Detail
Status
History
Print
Result
Start Time
Well# and Configuration
490H Serial Number
Control?
BI Lot#
Load#
Sterilizer#
Technician
Chemical Integrator?
Implant?
Cycle Parameters
Notes
no
2018-12DA
1
6
sdf
n/a
n/a
n/a
Daily control BI
2017-05-11 08:05:42
#2 1295
200299
3. The entered information is saved automatically to temporary web browser storage on
the users PC every 60seconds, or by leaving the Results Detailspage.
4. Print/File. Once the BI result is available, print or file the Results Detail page to create
a record. The page may be physically printed and/or saved as an electronicfile.
Important! Data is only stored for the last 100incubatedBIs.
Embedded software in the 3M™ Attest™ Autoreader 490H saves the data from the
autopopulated (i.e., green highlighted) fields. The application relies on the temporary
storage in the users web browser to save the data in the userpopulated fields. In
both cases, data is only stored for the last 100records, i.e., the 101st incubated BI will
overwrite the information saved for the 1st incubated BI. To retain the Results Detail
information for future reference it is best practice to print the page or save to an electronic
file as soon as the BI result isavailable.
10 11
1
Using the BI HistoryPage
Status
History
3M™ Attest™ Auto-reader 490H
Well# and Configuration
#3 1295
#2 1295
#1 1295
#10 1295
#3 1295
#2 1295
#1 1295
#4 1295
#3 1295
#2 1295
Start Time
2017-05-11 13:51:49
2017-05-11 08:05:42
2017-05-11 08:03:56
2017-05-07 11:55:16
2017-05-07 11:06:44
2017-05-07 08:03:19
2017-05-07 08:02:43
2017-05-04 08:57:51
2017-05-04 08:57:12
2017-05-04 08:01:47
Result
---
+
+
ID
1
2
3
4
5
6
7
8
9
10
To view or print an individual record, click on the ID number of the desired record to
navigate to the Results Detail page for thatBI.
Note 1: Column 1, ID is the assigned ID number with ID 1representing the newest
record and ID 100representing the oldest record. For convenience, all columns are
sortable; to help find a particular record, simply click once on the column heading to sort
in ascending order and click a second time to reverse theorder.
Note 2: The History page refreshes less frequently than the Status page. Until the BI result
is available, the History page displays ••• in the Results column indicating incubation is
stillinprocess.
Using the ConfigurationPage
Certain setup and configuration options are available on the passwordprotected
3M™ Attest™ Autoreader 490H Web App Configuration page. Ideally, the 3M™ Attest™
Autoreader 490H should be empty (i.e., have no incubating BIs) when it is reconfigured.
Navigate to the Configuration page by enteringeither:
1) http://attestxxxxxx/protect/config.htm (where xxxxxx is the 6digit unit serial number), or
2) http://xxx.xxx.xxx.xxx/protect/config.htm (where xxx.xxx.xxx.xxx is the IP address)
in the web browser address bar and pressing Enter. A security screen will appear. Fill in
the fields asfollows:
User name:manager
Password: Attest
and clickOK.
Click on the desired radio buttons to changesettings.
Language
Selected setting indicates language in which text on 3M™ Attest™ Autoreader 490H Web App pages will appear on the PC/mobile device screen.
Pushbutton
Configuration
Selecting Enable
allows the user to configure the 3M™ Attest™ Autoreader 490H from the buttons on the unititself.
Selecting Disable
prevents the user from being able to configure the 3M™ Attest™ Autoreader 490H from the buttons on the unit itself.
Buzzer Configuration
Selecting Enable
enables the audible alarm. The speaker icon will appear on the 3M™ Attest™ Autoreader 490H LCDpanel.
Selecting Disable
disables the audible alarm. The speaker icon will disappear from the 3M™ Attest™ Autoreader 490H LCD panel.
Attest Auto-reader
490HNickname
Naming the 3M™ Attest™ Autoreader 490H may be useful in facilities with multiple units. The assigned nickname will appear on the 3M™ Attest™
Autoreader 490H Web App Status page.
Enable DHCP
Default: Setting is checked indicating the Web App will usethe Dynamic IP address automatically assigned when the 3M™ Attest™ Autoreader 490H is
connected to the network. Remove the checkif you wish to use a Static IP address assigned by your facility IT.
IP Address Enter Static IP address assigned by IT.
Gateway Enter Gateway.
Subnet Mask Enter Subnet Mask.
Primary DNS Enter Primary DNS.
Secondary DNS Enter Secondary DNS.
MAC Address
XX:XX:XX:XX:XX:XX
(Unique MAC address assigned to device. This value cannot be changed.)
Use Computer Time
Check this box if you wish to set the clock onboard the 3M™ Attest™ Autoreader 490H using the computers clock.
Attest Auto-reader
490H Time
Alternatively, leave the Use Computer Time box uncheckedand complete the date and time boxes to set the 3M™ Attest™ Autoreader 490H clock.
After changing desired settings, click on Save Config button to save your changes. A new screen confirming the settings were successfully changedappears.
12
1
TROUBLESHOOTING THE 3M ATTEST AUTOREADER 490H WEB APP
Issue Problem Solution
Unable to access 3M™ Attest™
Autoreader 490H Web App on
networked computer
3M™ Attest™ Autoreader 490H and/or
computer not connected tonetwork.
Autonegotiation issue between the
3M™ Attest™ Autoreader 490H and facility
networkswitch.
Ensure 3M™ Attest™ Autoreader 490H Ethernet cable is connected to a live jack and
that connection to 3M™ Attest™ Autoreader 490H issecure.
Ensure computer is connected tonetwork.
If failure is with connection attempted using 3M™ Attest™ Autoreader 490H serial
number URL, try connecting using IP addressURL.
Switch port setting must be set at 10Mbps andhalfduplex.
Contact facility IT or 3M if problem persists.
Unable to access 3M™ Attest™
Autoreader 490H Web App on
mobile device
3M™ Attest™ Autoreader 490H not connected
tonetwork.
For security reasons, facility firewall may prevent
mobile devices not connected to the facility
network from connecting to secure IP addresses.
Ensure 3M™ Attest™ Autoreader 490H Ethernet cable is connected to a live jack and
that connection to 3M™ Attest™ Autoreader 490H issecure.
Contact facility IT for their recommendation on connecting to the secure network.
Solutions may include enabling WiFi on the mobile device and signing into the facility
network or connecting to the facility virtual private network (VPN) on the mobile device.
Data entered by user on Results
Detail page disappears
User entered data is written to temporary
webbrowser storage. Browser may have
cleareddata.
Set web browser to accept (allow or enable)cookies.
As a best practice, print or save Results Detail record as soon as BI result is final.
BI result displayed on
3M™ Attest™ Autoreader 490H
LCD display does not appear on
Results Detail page
The Results Detail page has not refreshed yet.
Use your browser to refresh the Results Detail page, or wait up to 60seconds for the
page to automatically refresh.
Results Detail page will not open
from the Status page
The Results Detail page only opens from the
Status page for occupied 3M™ Attest™
Autoreader 490H wells.
Do not attempt to navigate to the Results Detail page from unoccupied wells on the
Status page.
REPAIR ANDREPLACEMENT
In the U.S.A., 3M™ Attest™ Autoreaders 490H must be repairedat:
3M Health Care ServiceCenter
Suite 200, Bldg.502
3350Granada AvenueNorth
Oakdale, MN55128
18002926298
Fax:18007708016
Outside of the U.S.A., contact your local 3M Subsidiary.
If you have questions, call our Customer Service number:18002926298.
Made in the U.S.A. of globally sourced materials by 3M Health Care.
3M Health Care
2510Conway Ave
St. Paul, MN55144
18002283957
www.3M.com/healthcare
© 2017, 3M. All rightsreserved.
3M and Attest are trademarks of3M.
Used under license inCanada.
Issue Date: XXXX-XX
3M Deutschland GmbH
Health Care Business
Carl-Schurz-Str. 1
41453 Neuss
Germany
Made in U.S.A. by
3M Health Care
2510 Conway Ave.
St. Paul, MN 55144
1-800-228-3957
3M.com/Medical
3M Deutschland GmbH
Health Care Business
Carl-Schurz-Str. 1
41453 Neuss
Germany
© 2017, 3M. All rights reserved.
3M and Attest are trademarks of 3M.
Used under license in Canada.
Issue Date: 2017-03
34-8720-4946-4
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3M Attest™ Auto-reader, 490 Operating instructions

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